FDA-Device2023-05-24Class I
ASM Replacement Battery, Component Number SUB0000594
ICU Medical Inc
Hazard
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Sold states
worldwide
Affected count
344 units
Manufactured in
600 N Field Dr, N/A, Lake Forest, IL, United States
Products
ASM Replacement Battery, Component Number SUB0000594
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1568-2023Don't want to check this manually?
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